Sharps Terminator destroys syringe needles immediately after use
European Union (EU) Medical Device Directive (MDD) Changes ...
In September 2007, a new medical device directive, 2007/47/EC, was approved which sets out to clarify and update the current Medical Device Directive (MDD) and Active Implantable Medical Device Directive (AIMD). Compliance with requirements of the European Union’s (EU) Medical Device Directive (MDD) is shown by placing the CE marking on the marketed product and supplying the device with a declaration of conformity. Whilst most changes in the new directive are clarifications of existing regulations, there will still be a significant impact on the medical device industry with it. Companies will need to adapt and conform to these new directives before the... European Union (EU) Medical Device Directive (MDD) Changes: Industry Impact Analysis....
European Union Medical Device Directive - News
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Ekso Bionics Bestowed With CE Mark Henceforth, all medical devices produced by Ekso Bionics will be certified in over 30 European Union and EFTA countries. European rehabilitation facilities are already placing orders for the company's newest bionic suit, Ekso, which will be shipped to |
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European Commission study recommends changes to medical device and drug laws If adopted, the proposed changes would exempt medical devices altogether from REACH due to industry concerns that “under REACH the risks of using a substance in a medical device could be considered too high, while under the Directives on medical |
How International Regulations Are Changing American Supply Chains
High Concern (SVHC) list each year—and Restriction of Hazardous Substances Directive (RoHS) expanding its scope (medical devices will be included as of 2013), any company that sells into the EU, or has a supply chain that touches any EU country,
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Rejected cranberry wins EU medical UTI claim
Cranberry has won a medical claim for UTI treatment in the EU Dutch-based Medical Brands achieved the 'Class IIa medical device' registration via Germany that will permit it to make 'treats UTI' claims for its Cranberry-Active product in the European
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RoHS recast - Is your company ready yet? Directive 2011/65/EU, better known as RoHS 2 is a recast of legislation originally introduced in 2002. The scope is widened to include products previously excluded, such as medical devices and industrial equipment. In addition, manufacturers are now |
High Concern (SVHC) list each year—and Restriction of Hazardous Substances Directive (RoHS) expanding its scope (medical devices will be included as of 2013), any company that sells into the EU, or has a supply chain that touches any EU country,
Cranberry has won a medical claim for UTI treatment in the EU Dutch-based Medical Brands achieved the 'Class IIa medical device' registration via Germany that will permit it to make 'treats UTI' claims for its Cranberry-Active product in the European